MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK ROTALINK¿ PLUS; CATHETER, CORONARY, ATHERECTOMY

Model Number H749236310030

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 11/18/2016

Event Type  Death  

Manufacturer Narrative

Device evaluated by mfr: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).

Event Description

Same case as mdr id: 2134265-2016-11337, 2134265-2016-11338, 2134265-2016-11339, 2134265-2016-11340, 2134265-2016-11343, 2134265-2016-11355, 2134265-2016-11341, 2134265-2016-11342, 2134265-2016-11380, 2134265-2016-11378, 2134265-2016-11379.It was reported that patient death occurred.The target lesion was located in the left anterior descending artery.During testing of a 1.50mm rotalink¿ plus and rotawire guide wire with the rotablator console and a dynaglide foot pedal, the system baseline tested "okay" outside the patient.Rotational atherectomy was performed however, the burr stopped spinning and a hissing noise was noted from the nitrogen tank to the console.It was further reported atherectomy was discontinued and several boston scientific balloons and stents were utilized.The patient expired.Additional information was requested but not available.

• Brand Name: ROTALINK¿ PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6196607
• MDR Text Key: 63048497
• Report Number: 2134265-2016-11336
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: (01)08714729228363(17)20180930(10)19842632
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: H749236310030
• Device Catalogue Number: 23631-003
• Device Lot Number: 19842632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2016
• Initial Date FDA Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONSOLE: ROTA CONSOLE; DYNAGLIDE FOOT PEDAL; GUIDE WIRE: ROTAWIRE
• Patient Outcome(s): Death